NCT00747097已完成2 期
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract
- •signed written informed consent
- •age > 18
- •WHO PS 0 or 1 at study entry
- •measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria
- •adequate renal (serum creatinin<1.5x upper reference range), liver (total bilirubin<2x upper reference range) and hematopoietic functions (PMN>1,5x109/L, platelets>100x109/L)
- •life expectancy of at least 12 weeks
- •effective contraception throughout the study for both male and female patients if the risk of conception exists
排除标准
- •uncontrolled concurrent CNS, cardiac, infectious diseases
- •previous exposure to epidermal growth factor targeting therapy
- •known hypersensitivity to any components of study treatments
- •previous chemotherapy for this cancer
- •previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- •pregnancy or breast feeding
- •medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
研究组 & 干预措施
1
Experimental
gemcitabine+cetuximab
干预措施: gemcitabine + cetuximab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6 months
次要结局
- overall survival, objective response, safety(12 months)
研究者
研究点 (1)
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